Bio-Path(US:BPTH)2020-05-14 20:11Financial Performance - As of March 31, 2020, the company had an accumulated deficit of $59.7 million and reported a net loss of $3.3 million for the three months ended March 31, 2020, compared to a net loss of $1.5 million for the same period in 2019[56]. - Net loss from operations for Q1 2020 was $3.3 million, an increase of $1.8 million (approximately 120% increase) compared to Q1 2019[73]. - Net loss per share for Q1 2020 was $0.90, compared to $0.89 for Q1 2019[74]. - Cash balance at March 31, 2020 was $17.9 million, a decrease of $2.5 million (approximately 12.3% decrease) compared to December 31, 2019[76]. - Net cash used in operating activities for Q1 2020 was $2.5 million, an increase of $0.5 million (approximately 25% increase) compared to Q1 2019[77]. - No financing activities occurred in Q1 2020, while net cash provided by financing activities in Q1 2019 was $20.3 million[78]. - The company has not generated significant revenues to date and relies on public and private offerings for funding[75]. Drug Development - The company has four drug candidates in development targeting at least five different cancer indications, with the lead candidate, prexigebersen, in a Phase 2 clinical trial for acute myeloid leukemia (AML) patients[50]. - The FDA cleared an IND application for the second drug candidate, Liposomal Bcl-2 (BP1002), which targets the Bcl-2 protein involved in cell survival in up to 60% of cancers[52]. - The company is awaiting FDA approval for a modified amendment to add a triple combination treatment of prexigebersen, decitabine, and venetoclax for AML and MDS patients, expected by summer 2020[50]. - The company is developing Liposomal STAT3 (BP1003) as a potential treatment for pancreatic cancer, non-small cell lung cancer, and AML, with IND enabling studies expected to be completed in 2020[53]. - The company has a new product identification template to evaluate potential new drug candidates for its development pipeline, focusing on systemic delivery and antisense RNAi nanoparticles[54]. Operating Expenses - The company expects to incur significant operating losses as it expands drug development programs and commercialization efforts, with no current revenue generation anticipated for many years[61]. - Research and development expenses are expected to be substantial and increase over time, with costs associated with clinical trials and development of drug candidates being highly uncertain[66]. - Research and development expense for Q1 2020 was $2.0 million, an increase of $1.6 million (approximately 429% increase) compared to Q1 2019[69]. - General and administrative expense for Q1 2020 was $1.3 million, an increase of $0.2 million (approximately 20% increase) compared to Q1 2019[72]. - The company expects to continue incurring significant operating expenses for clinical trials and regulatory approvals, requiring substantial additional capital[89]. Capital and Financing - The company plans to finance its cash requirements through cash on hand, operations, debt financings, and equity offerings, with no current lines of credit or arranged access to debt financing[56]. - The company had no material off-balance sheet arrangements as of March 31, 2020[90]. - The company has received a second patent for its DNAbilize® technology, which is intended for use in treating cancers, autoimmune diseases, and infectious diseases[54].